{"id":4171,"date":"2026-09-07T15:12:37","date_gmt":"2026-09-07T15:12:37","guid":{"rendered":"https:\/\/sanyangmedical.com\/mdr-transition-deadline\/"},"modified":"2026-09-07T15:12:37","modified_gmt":"2026-09-07T15:12:37","slug":"mdr-transition-deadline","status":"publish","type":"post","link":"https:\/\/sanyangmedical.com\/es\/mdr-transition-deadline\/","title":{"rendered":"EU MDR Transition Timeline: 2027-2028 Deadlines"},"content":{"rendered":"

The EU MDR transition has set a phased deadline that runs past 2027, which means a device placed on the EU market under the older Directive has to be moved to the Medical Device Regulation by a set window. The deadline depends on the device class and the certificate, so it is not one date for everyone.<\/p>\n

Why the MDR timeline matters<\/h2>\n

The Medical Device Regulation (MDR) replaces the older active implantable and medical device Directives. A device already on the market can continue to be sold under the Directive for a transition period, but the period is capped and it is not the same for every device. A surgical table or an OR light falls into a class, and the transition window for that class sets when it must comply with MDR.<\/p>\n

\"EU
\n\"EU<\/p>\n

Deadline drivers compared<\/h2>\n\n\n\n\n\n\n\n\n
Driver<\/th>\nHow it sets the date<\/th>\nWhy it matters<\/th>\n<\/tr>\n<\/thead>\n
Device class<\/td>\nHigher class, later date<\/td>\nSets the transition window<\/td>\n<\/tr>\n
Certificate<\/td>\nCurrent vs expired<\/td>\nAn expired certificate fails<\/td>\n<\/tr>\n
Notified body<\/td>\nAvailability<\/td>\nSets the audit timing<\/td>\n<\/tr>\n
Market<\/td>\nEU placement<\/td>\nRules apply on the EU market<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

The device class and the certificate are the two drivers. A higher-class device gets a later transition window, and a device with an expired certificate is no longer on the market. Confirm the class of your device and the state of your certificate, because that is what sets your date.<\/p>\n

For a device sold into the US, the US quality system for medical devices is a separate, overlapping set of rules, so a device has to meet the requirements of each market it enters.<\/p>\n

See the US Federal Trade Commission on commercial claims<\/a> for the accuracy behind a compliance claim.<\/p>\n

OEM: an MDR transition term<\/h2>\n\n\n\n\n\n\n\n\n
Commercial term<\/th>\nTypical range<\/th>\n<\/tr>\n<\/thead>\n
MOQ (per device)<\/td>\n1-10 units<\/td>\n<\/tr>\n
Technical file review<\/td>\n30-60 days<\/td>\n<\/tr>\n
Bulk<\/td>\n40-60 days<\/td>\n<\/tr>\n
Packing<\/td>\nCarton + pallet<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Confirm the MOQ, the technical file review and the bulk time before you commit. Exact MDR class, certificate state and transition date: \u3014\u5f85\u5de5\u5382\u786e\u8ba4\u3015.<\/em><\/p>\n

If you want to plan a device compliance timeline, see our medical device range<\/a> so the class and the transition line up.<\/p>\n

FAQ about the EU MDR transition<\/h2>\n

What is the EU MDR transition?<\/h3>\n

The phased move of devices from the older EU medical device directives to the Medical Device Regulation, with a transition window that depends on the device class.<\/p>\n

Is there one deadline for all devices?<\/h3>\n

No. The deadline depends on the device class and the certificate, so a higher-class device gets a later window and a device with an expired certificate is no longer on the market.<\/p>\n

What sets my transition date?<\/h3>\n

The device class and the state of your certificate. Confirm the class of your device and whether the certificate is current.<\/p>\n

What happens if I miss the deadline?<\/h3>\n

The device can no longer be placed on the EU market under the Directive, so it must comply with MDR. Confirm the class and the certificate to avoid the gap.<\/p>\n